Robert Feltz Email & Phone Number

Philadelphia, Pa, Us

Bethlehem, Pennsylvania, United States

1510 Delp Dr, Harleysville Pa 19438

Spearheaded restructuring of laboratory workflows, optimizing efficiency, and reducing turnaround times. Implemented best practices in program management that enhanced overall operational performance.Improved laboratory KPIs within the quality management system leading to reduced open investigation times and CAPA adherence.Drove the implementation of new laboratory technology, including chromatography and particle size data management systems to enhance analytical capabilities. Fostered collaboration with cross-functional manufacturing and quality assurance teams, facilitating effective communication between research and development and operational teams. This approach expedited project timelines and improved overall project outcomes.

Manage a team of scientists within the analytical R&D department. Responsible for ANDA submission of solid and liquid oral dosage forms, parenterals, and injectables.Responsible for review and approval of:• Analytical method validation protocols and reports (HPLC, GC, ICP-MS)• Elemental Impurity Risk Assessments• Extractable and Leachable experimental design and reports• ANDA submission modules• Dissolution method development reports as per USP <1092> for both routine testing and in-vitro in-vivo comparison.Author and reviewer of FDA communications including information requests, complete response letters, and discipline review letters. Serve as primary scientific reviewer for contract research organizations and third party research and development projects. Serve as subject matter expert in identifying chemical degradation pathways, impurity purification, and impurity identification.

Greater Philadelphia Area

Greater Philadelphia Area

Project leader and subject matter expert from API release through drug product ANDA submission. Responsible for design of experiments, method development, validation and verification. Supervised junior scientists during project execution including: reverse engineering of both solid and liquid oral dosage forms, FDA response letters, process validation, method validation and transfer and pre-formulation support.

Morgantown, Wv

Developed HPLC methods used to analyze and control API, Production Intermediates and Finished Products in a cGMP environment. Strong experience in HPLC using TUV, PDA and Refractive Index detectors with additional knowledge of FT-IR, UV-VIS, Karl Fischer titration and Dissolution development. Very competent using Waters Alliance HPLCs, Acquity UPLCs and Empower analytical software. Experienced in applying USP/BP/EP/JP compendia to drug product submission process. Good understanding of cGMP with hands-on cGMP experience during the method development process and throughout long-term drug stability programs.

Kenilworth, Nj

Worked as a Synthetic Organic Chemist responsible for small molecule drug design, synthesis and analytical analysis of analogs from milligram to kilogram scale. Explored and enhanced structure-activity relationships of heteroaromatic pre-clinical candidates. Demonstrated expertise in multi-step syntheses and compound purification. Regularly characterized compounds using NMR, IR, GC, HPLC and LCMS

Ms, Chemistry

Bs, Chemistry